On July 6, 2025, the "More Precision × High Quality × Long-term Survival · Experts Discuss the Future Vision of MET+ and ASKC202 Tablet Phase III Clinical Investigator Meeting", sponsored by Jiangsu Aosaikang Pharmaceutical Co., Ltd.(abbreviated as "ASK") was held in Nanjing. Professor Zhou Caicun from Shanghai East Hospital and experts from 54 Medical centers nationwide attended the meeting.
The ASKC202 Phase III registration clinical study is a randomized, controlled, open-label, multicenter Phase III trial evaluating the efficacy and safety of ASKC202 tablets combined with Limertinib tablets compared to Platinum Analogue -based doublet Chemotherapy in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring MET amplification/overexpression after failure of EGFR-TKI treatment. The leading unit for this Phase III study is Shanghai East Hospital, with Professor Zhou Caicun serving as the principal investigator.
ASKC202 tables, as a self-developed, highly selective small-molecule c-MET inhibitor by ASK, have demonstrated promising clinical data in earlier studies, which were presented at multiple international conferences. Its impressive objective response rate (ORR) suggests the potential to redefine the treatment paradigm for MET+ patient populations.
Remarks by Professor Zhou Caicun
Professor Zhou noted that,NSCLC patients with MET amplification who develop resistance to EGFR-TKIs, combining third-generation EGFR-TKIs with c-MET inhibitors has emerged as a novel therapeutic strategy. Many ongoing studies, such as the SACHI study presented at this year's ASCO, have shown improved ORR and a median progression-free survival (mPFS) of 8.2 months. However, no significant difference in median overall survival (mOS) was observed between groups, indicating unmet medical needs in this field. He emphasized that early-phase data of ASKC202, including higher ORR and prolonged PFS, suggest the combination therapy may improve OS and provide optimal treatment solutions for this patient population.
Remarks by Professor Xiong Anwen
Professor Xiong Anwen (Shanghai East Hospital) shared the Phase I/II clinical trial data, demonstrating that ASKC202 tablets showed favorable tolerability and excellent antitumor efficacy across monotherapy and combination regimens with Limertinib tablets for EGFR-TKI-resistant NSCLC. These data strongly support the initiation of the Phase III registration study.
ASK's clinical team provided a detailed report of the ASKC202 Phase III clinical trial protocol, including the research background, Phase III study design, and future development plans. Key aspects such as study objectives, inclusion/exclusion criteria, trial procedures, operational highlights, and endpoint evaluations were thoroughly explained.
Under Professor Zhou Caicun's moderation, investigators engaged in in-depth discussions on the clinical trial protocol and processes. Consensus was reached on critical aspects including patient screening, inclusion criteria, central laboratory implementation, follow-up procedures, and endpoint assessment, laying a solid foundation for the execution of the ASKC202 Phase III trial. Experts expressed high expectations for the upcoming Phase III study's evaluation of efficacy and safety.
The investigator meeting concluded successfully, marking a new milestone in the ASKC202 research journey. ASK will continue to prioritize innovation and work together with experts nationwide to bring hope and benefits to more cancer patients in China.